Endoscopic suture apparatus

ABSTRACT

A holding member has an opening portion which opens to an distal end. The opening portion, the distal end of an endoscope and a holding member define a treatment space. A clamping member can project and retreat from and into the opening portion through the treatment space. The puncture member can move in the treatment space, in a direction that intersects with the longitudinal direction of the endoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/395,077, filed Jul. 11, 2002.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an endoscopic suture apparatus that canbe endoscopically inserted into a living body cavity and can suture orligate organic tissues. More particularly, the invention relates to anendoscopic suture apparatus for performing suture to treat a damagedpart of the tissue of the digestive canal or to reliably arresthemorrhage in a bleeding region and to form an artificial valve in thetreatment of a gastro-esophageal reflux disease.

2. Description of the Related Art

In general, tissues in the body of a patient are sutured in a surgicaloperation nowadays. Naturally, the patient's body cavity must be incisedin the case of the surgical operation. The patient inevitably suffers aheavy invasion. Further, the patient must bear considerable costsincluding expenses of postoperative hospitalization that is required.

In view of this, it is desired that a medical treatment method beestablished, which uses a low-invasion oral endoscope and which obviatesthe necessity of incision of the patient's body.

The gastro-esophageal reflux disease (GERD) is one of diseases thataffect more and more people these days. The principal symptoms of thisdisease include heartburn and mucosal break in the gullet. The diseaseis characterized in that it causes heavy pain to patients despite itsbenignancy. Hence, many patients require treatment. The main cause is adecrease in the function of the lower esophageal sphincter (LES) in thelower part of the gullet, which makes gastric acid flow upstream intothe gullet.

A gastric-acid secretion inhibitor such as a proton-pump inhibitor isadministered for treatment for the GERD. If the GERD is mild, itssymptoms can be mitigated. A radical cure can be expected. However, acase wherein the function of the LES is lowered considerably and aserious case, such as a hiatal hernia, which involves an anatomicalproblem, can enjoy only a low effect of medication. These cases requirescontinuous administration, inevitably entailing high cost. Therefore, asurgical operation is applied to a serious GERD case. The Nissenfundoplication and Toupet methods are widely used as effectivetechniques.

In either method, the function of the LES is improved by wrapping theLES portion in the wall of the stomach, achieving a high curativeeffect. Recently, the laparoscopic technique has been established fortreatment of lower invasion. However, there are numerous patients, andthis disease is a benign disease, unlike cancer. There is a demand forthe establishment of a method of treatment using a lower-invasion oralendoscope. To meet the demand, a method, or a technique, has beendevised. In this method, a backward flow of gastric acid is prevented byusing an artificial valve that is formed by ligating and bulging anorganic tissue.

U.S. Pat. No. 5,792,153 (PCT National Publication No. 10-500318), Jpn.Pat. Appln. KOKOKU Publication No. 6-44,913, and Jpn. Pat. Appln. KOKAIPublication No. 11-313,826, for example, disclose endoscopic sutureapparatuses.

The suture apparatus disclosed in U.S. Pat. No. 5,792,153 (PCT NationalPublication No. 10-500318) and Jpn. Pat. Appln. KOKOKU Publication No.6-44,913 is mounted on the far-side end of the endoscope. This sutureapparatus has a cavity having an opening in the flank. The cavityconnects a biopsy channel and a suction channel. The cavity is subjectedto vacuum suction through the suction channel. A part of an organictissue is thereby drawn, in the shape of a U, into the cavity. A needleand a thread carrier in the biopsy channel are stabbed into the U-shapedpart to suture the channel.

As described in Jpn. Pat. Appln. KOKAI Publication No. 11-313,826, a capis provided on the tip of the endoscope, and a cavity having an openingis provided in the flank of the cap. In the tip, a suture tool is heldby a holding forceps that is provided on the distal end portion of asheath.

The organic tissue is sucked into the cavity through the opening made inthe flank of the cap. The suture tool is stabbed into the organismtissue by using the holding forceps.

Any apparatus described in U.S. Pat. No. 5,792,153 (PCT NationalPublication No. 10-500318), Jpn. Pat. Appln. KOKOKU Publication No.6-44,913, and Jpn. Pat. Appln. KOKAI Publication No. 11-313,826 isdesigned so that the organism tissue is sucked into the cavity havingthe opening in the flank of the tip portion of the endoscope.

Therefore, the cavity must be positioned, with the opening opposing atarget region of the organism tissue, and then be depressurized. Thus,the opening of the cavity can hardly be moved to the target region.Consequently, the organism tissue cannot be fully drawn into the cavitywhen the cavity is depressurized only.

Further, a part of the stomach must be sucked in suturing the organismtissue to form an artificial valve for use in treatment of, for example,a gastro-esophageal reflux disease. However, the stomach wall is thickerthan the tissues of the gullet and the like and is composed of alumen-side mucous membrane, intermediate proper muscularis, andcoat-side serous membrane. High fluidity is present, in particularbetween the mucous membrane and the proper muscular. To form a boss of asize suitable as a valve, it is essential to shorten and swell thetissue after capturing the proper muscularis. The conventionalapparatuses can indeed capture the mucous membrane. However, it cannoteasily capture the proper muscularis that underlies the mucous membrane.It is quite probable that the valve thus formed cannot be large andthick enough to prevent a backward flow reliably. To suture a damagedpart securely, for example, it is necessary to suture the tissueincluding the proper muscularis or serous membrane. With theconventional apparatuses, however, it is difficult to capture the propermuscularis or serous membrane.

The object of the present invention is to provide an endoscopic sutureapparatus capable of easily approaching a target region of an organictissue and capturing the organism tissue in a holding portion to sutureit.

According to an aspect of this invention, there is provided a endoscopicsuture apparatus which comprises: an endoscope; a puncture member whichhas at least one sharp tip; a holding member which holds the puncturemember and which is removably attached to an distal end of theendoscope; a clamping member which is configured to move back and forthwith respect to the endoscope and to clamp living tissues; and a drivemember which is configured to move the puncture member. The holdingmember has an opening portion which opens to an distal end. The openingportion, the distal end of the endoscope and the holding member define atreatment space. The clamping member is configured to project andretreat from and into the opening portion through the treatment space.The puncture member is configured to move in the treatment space, in adirection that intersects with a longitudinal direction of theendoscope.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 a perspective view of an endoscopic suture apparatus according toa first embodiment of the present invention;

FIG. 2 is a longitudinal sectional side view of a distal end portion ofthe suture apparatus according to the same embodiment;

FIG. 3 is a sectional view of the same embodiment taken along line A-Aof FIG. 2;

FIG. 4 is a sectional view of the same embodiment taken along line B-Bof FIG. 2;

FIG. 5 is a perspective view of a pusher according to the sameembodiment;

FIG. 6 is a perspective view of a staple according to the sameembodiment;

FIG. 7 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 8 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 9 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 10 is a sectional view showing a tissue sutured according to thesame embodiment;

FIG. 11 is a sectional view showing the way the cardiac region issutured according to a second embodiment of the present invention;

FIG. 12 is a sectional view showing the cardiac region sutured accordingto the second embodiment;

FIG. 13 is a perspective view of an endoscopic suture apparatusaccording to a third embodiment of the present invention;

FIG. 14 is a longitudinal sectional side view of the distal end portionof the suture apparatus according to the same embodiment;

FIG. 15 is a plan view of the distal end portion of the suture apparatusaccording to the same embodiment;

FIG. 16A is a perspective view of a receiving sheet according to thesame embodiment;

FIGS. 16B and 16C are sectional views of a cover portion;

FIG. 17 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 18A is a perspective view of a receiving sheet according to amodification of the same embodiment;

FIG. 18B is a sectional view of a cover portion;

FIG. 19 is a perspective view of an endoscopic suture apparatusaccording to a fourth embodiment of the present invention;

FIG. 20 is a longitudinal sectional side view of the distal end portionof the suture apparatus according to the same embodiment;

FIG. 21 is a plan view of the distal end portion of the suture apparatusaccording to the same embodiment;

FIG. 22 is a sectional view of the same embodiment taken along line C-Cof FIG. 20;

FIG. 23A is a perspective view of a staple according to the sameembodiment;

FIG. 23B is a perspective view of a hollow needle;

FIG. 23C is a perspective view of a staple;

FIG. 24 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 25 is a sectional view showing a tissue sutured according to thesame embodiment;

FIG. 26 is a perspective view of an endoscopic suture apparatusaccording to a fifth embodiment of the present invention;

FIG. 27 is a longitudinal sectional side view of the distal end portionof a hollow needle according to the same embodiment; * FIG. 28 is aperspective view of an endoscopic suture apparatus according to a sixthembodiment of the present invention;

FIG. 29 is a longitudinal sectional side view of the distal end portionof the suture apparatus according to the same embodiment;

FIG. 30 is a plan view of the distal end portion of the suture apparatusaccording to the same embodiment;

FIG. 31 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 32 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIG. 33 is a longitudinal sectional side view of the distal end portionof the suture apparatus, showing the function of the same embodiment;

FIGS. 34A, 34B and 34C are side views showing the function of the sameembodiment and illustrating steps of procedure for suture;

FIG. 35 is a longitudinal sectional side view of an injection needle forendoscopic mucosal resection;

FIG. 36 is a side view of the injection needle;

FIG. 37 is a longitudinal sectional side view of the distal end portionof the injection needle;

FIG. 38 is a view illustrating operation for endoscopic mucosalresection;

FIG. 39 is a view illustrating the operation for endoscopic mucosalresection;

FIG. 40 is a view illustrating the operation for endoscopic mucosalresection;

FIG. 41 is a view illustrating the operation for endoscopic mucosalresection; and

FIG. 42 is a view illustrating the operation for endoscopic mucosalresection.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention will now be described withreference to the drawings.

FIGS. 1 to 10 show a first embodiment of an endoscopic suture apparatus.An endoscope 1 shown in FIG. 1 comprises a control section 2, a flexibleinsertion section 3, and a universal cord 4. The insertion section 3 iscomposed of a flexible tube portion 5, a bending tube portion 6, and atip portion 7. The control section 2 has a bending control portion 9 anda forceps tap 10.

As shown in FIG. 2, the forceps tap 10 communicates with a forcepschannel 11 that in connected to the tip portion 7 by the insertionsection 3. The sheath 13 of a grasping forceps 12 passes through theforceps tap 10. The grasping forceps 12 is used as a clamping member.The sheath 13 is formed of metallic multiple coils or a plastic tubestudded with blades, for example. A control section body 14 is providedon the near-side end of the sheath 13, and is fitted with a slider 15and a finger ring 16.

A grasping portion 17 in the form of a nipper-type forceps is providedon the far-side end of the grasping forceps 12. The grasping portion 17can be opened or closed as the slider 15 is moved. Further, the graspingportion 17 can be rotated to change its course as the control sectionbody 14 is turned.

The insertion section 3 of the endoscope 1 incorporates a puncturedevice 18. The puncture device comprises a cap 19, a sheath 20, and apuncture control portion 21. The cap 19 serves as a holding member thatis removably attached to the tip portion 7 of the endoscope 1. Thesheath 20 is formed of a flexible material such that it can follow thebending motion of the insertion section 3. The material may, forexample, be a plastic tube of fluoroplastic, polyethylene, polyamide,polyimide, polyurethane, any of various thermoplastic elastomers, or ametallic coil. Alternatively, the sheath 20 may be a plastic tube thatis reinforced with a metallic mesh lest it easily kink.

The sheath 20 is fixed to the insertion section 3 of the endoscope 1with a medical tape 22. The puncture control portion 21 is held near thecontrol section body 14 of the grasping forceps 12. A sheath joint 34 iscoupled to the distal end of the sheath 20.

A pusher member 23 for use as moving member (member for driving thepuncture-member) is movably fitted in the sheath 20. The pusher member23 is formed of a metallic stranded wire or the like. Its near-side endis coupled to a control slider 24 of the puncture control portion 21.

The cap 19 is made of relatively rigid material. Preferably, it shouldbe made of highly transparent material, such as polycarbonate ornorbornane resin, lest it should obstruct the view of the endoscope. Thecap 19 is shaped like a rectangular box. A cylindrical attachment 26 issecured on its proximal end portion by means of a connecting member 25.The cap 19 can be removably attached to the endoscope 1 by fitting theattachment 26 on the tip portion 7.

As shown in FIGS. 2 and 3, the cap 19 has flat lower and upper bases 27and 28. The bases 27 and 28 are separated left and right and opposed toeach other. A tip base 29 protrudes from the distal end portion of thelower base 27 toward the upper base 28. The cap 19 therefore has atreatment space 30 that is defined by the lower and upper bases 27 and28 and the tip base 29. Provided between the lower and upper bases 27and 28 is an opening portion 31 that opens to the distal end andconnects with the treatment space 30. The opening portion 31 opposes theforceps channel 11 of the tip portion 7. The grasping portion 17 cantherefore project and retract through it.

As shown in FIG. 4, the lower base 27 of the cap 19 has a guide bore 32.The bore 32 is broad in the horizontal direction and narrow in thevertical direction. A through hole 33 that faces the sheath 20 of thepuncture device 18 is made in the middle of the proximal end portion ofthe guide bore 32 with respect to the width direction. The sheath joint34 is set in screw engagement with the through hole 33 and connected tothe sheath 20. Thus, the pusher member 23 that is passed through thesheath 20 extends through the sheath joint 34 to the guide bore 32.

As shown in FIG. 5, a pusher 35 is coupled to the far-side end of thepusher member 23. It can move back and forth in the guide bore 32. Thepusher 35 is shaped like a square bar, is fixed to the pusher member 23at right angles thereto and extends in the width direction of the guidebore 32.

The guide bore 32 has a bent guide bore 36. The bent guide bore 36 isupwardly bent in a circular arc on its distal end. The bent guide bore36 communicates with a flat vertical guide bore 37 made in the tip base29.

The bent guide bore 36 contains a staple 38 for use as a puncturemember. As FIG. 6 shows, the staple 38 is a substantially U-shapedmember. It is formed of metal having elastic restoring force, such asNitinol, stainless steel or the like The staple 38 has a pair ofparallel prongs 40 that extend at right angles to a base portion 39. Apointed head 41 is attached to the distal ends of each prong 40. Thepointed head 41 is shaped like an arrowhead or cone. The proximal endface of the pointed head 41 has engaging surfaces 42.

The slopes of the pointed heads 41 of the staple 38 provided in the bentguide bore 36 touch a ridge portion 43 formed on the inner peripheralsurface of the vertical guide bore 37. The staple 38 is thereforepositioned not to jump out.

Further, the upper base 28 that faces the vertical guide bore 37 has aside aperture 44. A groove portion 45 is provided on the proximal endside of the inner peripheral surface of the side aperture 44. Receivingportions 46 defined by steps are provided on the both sides and thedistal end of the side aperture 44, respectively. Further, a receivingsheet 47 closes the side aperture 44. One side of the outer peripheraledge of the receiving sheet 47 is removably inserted into the grooveportion 45. The remaining three sides are supported on the receivingportions 46. The receiving sheet 47 is formed of a flexible sheet ofresin exhibiting good bio-compatibility, such as nylon, fluoroplastic orsilicone. The receiving sheet 47 can be punctured with the staple 38.

How the first embodiment operates will be described.

As FIG. 2 shows, the sheath 20 is fixed to the insertion section 3 ofthe endoscope 1 by using the medical tape 22. The attachment 26 of thecap 19 is fastened to the tip portion 7. The opening of the forcepschannel 11 of the tip portion 7 is set, opposing the opening portion 31of the cap 19. Then, the staple 38 is put into the bending guide bore 36of the cap 19. The sheath 20 of the puncture device 18 and the throughhole 33 of the cap 19 are connected by means of the sheath joint 34.

In this state, the insertion section 3 of the endoscope 1 is insertedinto the patient's body cavity through the mouth and throat. The bendingcontrol portion 9 is operated, guiding the tip portion 7 to a sutureregion under endoscopic observation. The suture region may be an incisedwound 50 of an organic tissue, as illustrated in FIG. 7. To suturetissue portions 50 a and 50 b on the opposite sides of the incised wound50, the opening portion 31 of the cap 19 is located close to the incisedwound 50.

Then, the control section body 14 of the grasping forceps 12 isoperated, moving the sheath 13 forwards. The grasping portion 17 is thusprojected forward from the space 30 of the cap 19 through the openingportion 31. The control section body 14 is then be turned. In this case,the sheath 13 can re-direct the grasping portion 17, making the samefacing the tissue portions 50 a and 50 b.

In this state, the surgeon puts the fingers on the finger ring 16 and onthe slider 15. He or she pushes the slider 15 forward, opening thegrasping portion 17 and pressing the grasping portion 17 against thetissue portions 50 a and 50 b. If the slider 15 is then moved backward,the grasping portion 17 is closed. When the portion 17 is closed, itholds the tissue portions 50 a and 50 b.

The control section body 14 may be then pulled to the hand side, asshown in FIG. 8. If so, the grasping portion 17 is retreated by thesheath 13. The tissue portions 50 a and 50 b, both held by the graspingportion 17, can be pulled into the space 30 of the cap 19 through theopening portion 31. If the control slider 24 is advanced, whilesupporting the puncture control portion 21 of the puncture device 18,the pusher member 23 moves forward in the sheath 20.

As the pusher member 23 moves forward, the pusher 35 moves from theguide bore 32 to the bent guide bore 36. The pusher 35 abuts on the baseportion 39 of the staple 38. If the pusher 35 is further moved forward,the pointed heads 41 of the staple 38 get over the ridge portion 43 ofthe vertical guide bore 37, projecting into the opening portion 31through the vertical guide bore 37.

The staple 38 is thus stabbed into the tissue portions 50 a and 50 bthat are pulled into the space 30 of the cap 19. The pointed heads 41penetrate the tissue portions 50 a and 50 b and then penetrate thereceiving sheet 47, as is illustrated in FIG. 9.

As the staple 38 are pushed onto the tissue portions 50 a and 50 b, bothtissue portions 50 a and 50 b are pushed in the same direction thestaple 38. Nonetheless, the upper base 28 holds the staple 38, enablingthe staple 38 to penetrate the tissue portions 50 a and 50 b.

If the slider 15 of the grasping forceps 12 is moved forward to open thegrasping portion 17, the tissue portions 50 a and 50 b are released fromthe grasping portion 17. The insertion section 3 of the endoscope 1 maythen be retreated. If so, the receiving sheet 47 slips out of the grooveportion 45 of the cap 19. The receiving sheet 47 is therefore separatedfrom the cap 19.

Thus, as shown in FIG. 10, the prongs 40 of the staple 38 penetrate thetissue portions 50 a and 50 b, the base portion 39 touches the tissueportion 50 b, and the pointed heads 41 of the prongs 40 touch thereceiving sheet 47 which in turn touches the other tissue portion 50 a.Further, the engaging surfaces 42 of the pointed heads 41 are broughtinto surface contact with the receiving sheet 47. This prevents thepointed heads 41 from slipping off the receiving sheet 47 and from thetissue portions 50 a and 50 b.

In the present embodiment, the cap 19 can easily approach a targetregion, and the staple 38 crossing the opening portion 31 can suture thetissue portions 50 a and 50 b, while the grasping forceps 12 is pullingthe tissue portions 50 a and 50 b in, through the opening portion 31 ofthe cap 19. Thus, the target region can be reliably sutured.

FIGS. 11 and 12 show a second embodiment. In this embodiment, theendoscopic suture apparatus used in the first embodiment is employed totreat patients with a gastro-esophageal reflux disease (GERD). How abulge portion 62 is formed in a cardiac region 61 will be described. AsFIG. 11 shows, the insertion section 3 of the endoscope 1 is insertedinto a gullet 63 of the patient, through the mouth and throat. When theinsertion section 3 reaches the stomach 64, the bent tube portion 6 isbent substantially, assuming a U shaped, in the stomach 64. The tipportion 7 therefore opposes the cardiac region 61. The cardiac region 61is observed from below through the endoscope 1.

Then, the control section body 14 of the grasping forceps 12 isoperated, projecting the grasping portion 17 ahead of the cap 19, as inthe first embodiment. A great-curvature tissue 65 of the cardiac region61 is held by means of the grasping portion 17. The bulge portion 62 canbe formed in the great-curvature tissue 65 as shown in FIG. 12. That is,the great-curvature tissue 65 drawn into the space 30 of the cap 19 byusing grasping portion 17, and the staple 38 is stabbed into thegreat-curvature tissue 65 and secured thereto.

FIGS. 13 to 18 show a third embodiment. The components similar to thoseof the first and third embodiments are designated at the same referencenumerals and will not be described. As FIGS. 14 and 15 depict, a movablebase 70, which corresponds to the upper base 28 of the cap 19 used inthe first embodiment, is supported on a support base 71 and held by apivot pin 72 for vertical rocking motion.

More specifically, the support base 71 is formed having a U-shaped planeconfiguration, and a fitting recess 74 is formed between a pair ofsupport arms 73. The proximal end portion of the movable base 70 has afitting protrusion 75 that can be fitted in the fitting recess 74. Thefitting protrusion 75 is penetrated by the pivot pin 72. The oppositeend portions of the pivot pin 72 are rockably inserted in a pin holes 76that are formed in the support arms 73, individually.

An arm portion 77 is formed integral with the proximal end portion ofthe fitting protrusion 75 of the movable base 70. The arm portion 77projects diagonally upward. The arm portion 77 is coupled to the distalend of a control wire 78. An urging spring 79, such as a leaf spring ortorsion spring, is provided between the arm portion 77 and the supportbase 71, and urges the movable base 70 downward so that it extendsparallel to the lower base 27.

The control wire 78 can move to pass through a sheath 80 that is coupledto the connecting member 25. The wire 78 is guided to the controlsection 2 along the insertion section 3 of the endoscope 1. The sheath80 is made of a flexible material. It can therefore bend as theinsertion section 3 is bent. The sheath 80 may be a plastic tube madeof, for example, fluoroplastic, polyethylene, polyamide, polyimide,polyurethane, any of various thermoplastic elastomers, or a metalliccoil. Alternatively, it may be a plastic tube that is reinforced with ametallic mesh lest it easily kink. Like sheaths 20, the sheath 80extends along the insertion section 3. It is fixed by medical tape.

A traction control portion 81 is provided on the near-side end of thecontrol wire 78. When the control wire 78 is pulled by the tractioncontrol portion 81, the arm portion 77 is pressed down against theurging force of the urging spring 79. When the arm portion 77 is presseddown, the distal end of the movable base 70 rocks upward around thepivot pin 72. The opening portion 31 therefore opens upwards.

The side aperture 44 in the movable base 70 is closed with the receivingsheet 47. The receiving sheet 47 is formed integral with cover portions82. The portions 82 are shaped like a bullet and provided for thepointed heads 41 of the staple 38, respectively. The receiving sheet 47has orifices 83 in those parts that face the cover portions 82. Theorifices 83 communicate with cover bores 84, individually. The pointedheads 41 of the staple 38 can be inserted into the cover bores 84through the orifices 83. The engaging surfaces 42 can engage openingedges 85 of the orifices 83, respectively.

How the third embodiment operate will be described. The componentsidentical to those of the first embodiment will not be described. As thecontrol wire 78 is pulled by means of the traction control portion 81,the grasping portion 17 projects ahead of the cap 19 and holds thetissue portions 50 a and 50 b.

When the control wire 78 is pulled, the arm portion 77 is pressed downagainst the urging force of the urging spring 79. As a result, thedistal end side of the movable base 70 rocks upward around the pivot pin72. The opening portion 31 therefore opens wide upwards.

As the tissue portions 50 a and 50 b, both held by the grasping portion17, are drawn into the space 30 of the cap 19 through the openingportion 31, wide areas of the tissue portions 50 a and 50 b can bepulled into the space 30 of the cap 19.

If the control slider 24 moves forward, with the puncture controlportion 21 of the puncture device 18 supported, the pusher member 23causes the pusher 35 to advance the staple 38. The pointed heads 41 ofthe staple 38 get over the ridge portion 43 of the vertical guide bore37. Then, they project into the opening portion 31 through the verticalguide bore 37.

Thus, the staple 38 is stabbed into the tissue portions 50 a and 50 bdrawn into the space 30 of the cap 19. The pointed heads 41 penetratethe tissue portions 50 a and 50 b. The pointed heads 41 also penetratethe orifices 83 of the receiving sheet 47 to be inserted into the coverbores 84. Then, the engaging surfaces 42 of the pointed heads 41 engagethe opening edges 85 of the orifices 83. Thus, they are prevented fromslipping out.

In the present embodiment, the wide areas of the tissue portions 50 aand 50 b can be pulled into the cap 19, while the movable base 70 isopening the opening portion 31 of the cap 19 wide. Further, the coverportions 82 of the receiving sheet 47, which envelops the pointed heads41 of the staple 38, can protect other tissues without allowing thepointed heads 41 of the staple 38 to be exposed in the body cavity. Themovable base 70 that corresponds to the upper base 28 is rotated in thisembodiment. Nevertheless, the lower base 27 may be rotated instead.

FIG. 18 shows a modification of the receiving sheet 47. Slits 86 areprovided extending from regions around the orifices 83 of the receivingsheet 47, to the respective sidewalls of the cover portions 82. Thusarranged, the slits 86 spread as the pointed heads 41 of the staple 38penetrate the orifices 83 of the receiving sheet 47. The pointed heads41 can therefore penetrate the receiving sheet 47 for a reducedresistance.

FIGS. 19 to 25 show a fourth embodiment. The components similar to thoseof the first and fourth embodiments are designated at the same referencenumerals and will not bed described.

The insertion section 3 of the endoscope 1 has a puncture device 90. Thepuncture device 90 comprises two sheaths 91, hollow needles 92, pushermembers 93, and a puncture control portion 94. The sheaths 91 arearranged along the insertion section 3 of the endoscope 1. The hollowneedles 92 can move, passing through the sheaths 91. The pusher members93 are formed of metallic wires or the like and can move, passingthrough the hollow needles 92. The puncture control portion 94 isprovided on the respective near-side ends of the sheaths 91.

The sheaths 91 are formed of flexible material and can bend as theinsertion section 3 is bent. It may be a plastic tube made of, forexample, fluoroplastic, polyethylene, polyamide, polyimide,polyurethane, any of various thermoplastic elastomers, or a metalliccoil. Alternatively, the sheaths 91 may be plastic tubes that arereinforced with a metallic mesh lest it should easily kink. The hollowneedles 92 are made of metal having elastic restoring force, such asNitinol, stainless steel, etc.

The puncture control portion 94 comprises a control portion body 95, aneedle slider 96, and a pusher slider 97. The control portion body 95 isprovided on the respective near-side ends of the two sheaths 91 andconnects the sheaths 91. The needle slider 96 is provided on therespective near-side ends of the two hollow needles 92 and connects andmoves the hollow needles 92. The-pusher slider 97 is provided on therespective near-side ends of the two pusher members 93 and connects andmoves the pusher members 93.

The lower base 27 of the cap 19 has two guide bores 98 for the twohollow needles 92. A bent guide bore 99 connects the guide bores 98 to avertical guide bore 100 that is provided in the tip base 29. The hollowneedles 92 can move forward and back in the guide bores 98, bent guidebore 99, and vertical guide bore 100. Slits 101 are cut in the innersurface of the vertical guide bore 100, each extending in the verticaldirection inside. Namely, the slits 101 are provided on the side of thespace 30 of the cap 19.

As FIG. 23B shows, the hollow needles 92 are so sharp that theirrespective distal end portions can be easily stabbed into the tissueportions 50 a and 50 b. The needles 92 have slits 102 that extendaxially from the distal end portions. A staple 103 is held in therespective distal end portions of the hollow needles 92.

The staple 103 is made of material having flexibility and goodbio-compatibility. It may be made of synthetic resin such as nylon 6,nylon 66 or the like. The staple 103 comprises a pair of rod-shapedstopper members 104 and a U-shaped bridge portion 105 that connectsthese stopper members 104.

The staple 103 is formed by the following method. First, an H-shapedmember 117 shown in FIG. 23C, which has the stopper members 104 providedintegrally on the opposite ends of a central portion 116, is formed byinjection molding. Then, the bridge portion 105 is formed by stretchingthe central portion 116. The stretched portion is bent into an U-shapedmember by means of thermoforming. Preferably, the degree of stretchingof the central portion 116 should range from 120 to 500%. This methodcan provide the stopper members 104 and the bridge portion 105 formedintegral with each other. The manufacturing cost is therefore low.Having been stretched, the bridge portion 105 exhibits high tensilestrength. The stopper members 104 of the staple 103 are inserted intothe hollow needles 92 through their respective distal end portions. Thebridge portion 105 projects outside through the slits 102.

How the fourth embodiment operates will be described.

As in the first embodiment, the grasping portion 17 holds the tissueportions 50 a and 50 b. The tissue portions 50 a and 50B are drawn intothe space 30 of the cap 19. After the tissue portions 50 a and 50 b aredrawn into the space 30, the needle slider 96 of the puncture controlportion 94 is moved forward. The two hollow needles 92 thereforeadvance. The guide bores 98, bent guide bore 99, and vertical guide bore100 guide the hollow needles 92 that are advancing. As FIG. 24 depicts,the hollow needles 92 holding the staple 103 penetrate the tissueportions 50 a and 50 b and project from the side aperture 44.

As the pusher slider 97 advances in this way, the pusher members 93moves forward in the hollow needles 92. The distal ends of the pushermembers 93 push the stopper members 104 of the staple 103 forward. Whenthe stopper members 104 project from the respective distal end portionsof the hollow needles 92, the stopper members 104 extend perpendicularto the bridge portion 105 by virtue of elastic restoring force. They arelocated in the side aperture 44.

If the needle slider 96 is then retreated, drawing the hollow needles 92out of the tissue portions 50 a and 50 b. Only the staple 103 remains inthe tissue portions 50 a and 50 b. The stopper members 104 touch theflank of the one tissue portion 50 a, while the bridge portion 105touches the flank of the other tissue portion 50 b, as shown in FIG. 25.Thus, the staple is prevented from slipping off. The suture is thuscompleted.

The staple 103 has the stopper members 104 that are formed integral withit. Hence, it is not necessary to arrange a receiving sheet 47 at theupper base 28 as in the first embodiment. The suture can be performed inthe present embodiment, without the upper base 28.

FIGS. 26 and 27 show a fifth embodiment. The components similar to thoseof the first, fourth and fifth embodiments are designated at the samereference numerals and will not be described.

Pipe-shaped pusher members 106 are moved, passing through the two hollowneedles 92. The near-side ends of the pusher members 106 are connectedto the pusher slider 97. Suture threads 107 are passed through the twopusher members 106, respectively. The respective near-side ends of thesuture threads 107 are led out from the pusher slider 97. The respectivefar-side ends of the suture threads 107 are connected to the respectivelongitudinal-direction middle portions of rod-shaped stopper members 108in the respective distal end portions of the hollow needles 92.

How the fifth embodiment operates will be described.

As in the fourth embodiment, the two hollow needles 92 are stabbed intothe tissue portions 50 a and 50 b after the tissue portions 50 a and 50b are held by the grasping portion 17 and drawn into the space 30 of thecap 19.

When the hollow needles 92 are drawn out of the tissue portions 50 a and50 b by retreating the needle slider 96, the stopper members 108 areleft with the suture threads 107 in the tissue portions 50 a and 50 b inthis embodiment. The stopper members 108 contact the flank of the onetissue portion 50 a.

The insertion section 3 of the endoscope 1 is then drawn out of thepatient's body cavity. The respective near-side ends of the two suturethreads 107 are thereby exposed outside the patient's body. The suturethreads 107 are then tied to form a knot (not shown) outside thepatient's body. The knot may be any one that is generally used in asurgical operation.

The knot is passed through the forceps channel 11 of the endoscope 1.This done, the endoscope 1 is inserted into the patient's body cavityand pushed into the patient's body cavity, by using a conventional knotpusher. When the knot reaches a region near the tissue portion 50 b, theknot pusher is pressed on to the tissue portion 50 b. At the same time,the opposite ends of the suture threads 107 are pulled, fixing the knot.

The operation described above is performed once or a plurality of times.The knot is thereby firmly fixed lest it should be untied. Finally,those parts of the suture threads 107 which are situated on the handside of the knot are cut by using an endoscopic scissors-type forceps orthe like. The remaining parts of the suture threads 107 are recoveredfrom the patient's body. Thereafter, the endoscope 1 and the knot pusherare drawn from the patient's body. The suture is thus completed.

In the present embodiment, the knot can be formed, with the length ofthe suture threads 107 adjusted to the size of the tissue portions 50 aand 50 b, especially their thickness. Thus, the tissue portions 50 a and50 b can be sutured securely.

FIGS. 28 to 34A, 34B and 34C show a sixth embodiment. The componentsimilar to those of the first, fourth and sixth embodiments aredesignated at the same reference numerals and will not be described.

The insertion section 3 of the endoscope 1 has the puncture device 90.The puncture device 90 comprises two sheaths 91, hollow needles 92, andpuncture control portion 94. The sheaths 91 extend along the insertionsection 3 of the endoscope 1. The hollow needles 92 can move, to passthrough the sheaths 91. The puncture control portion 94 is provided onthe respective near-side ends of the hollow needles 92.

The puncture control portion 94 comprises control portion a body 95 anda needle slider 96. The control portion body 95 is provided on therespective near-side ends of the two sheaths 91 and connects the sheaths91. The needle slider 96 is mounted on the respective near-side ends ofthe two hollow needles 92. The slider 96 connects and moves the hollowneedles 92. In addition to the sheaths 91, two suture thread sheaths 110are attached to the insertion section 3 of the endoscope 1. The distalends of the suture thread sheaths 110 are coupled to the upper base 28.Suture threads 111 are passed through the suture thread sheaths 110,respectively. The far-side ends of the suture threads 111 extend to theside aperture 44 of the cap 19. Loop portions 112 are formed on therespective far-side end portions of the suture threads 111,respectively. The loop portions 112 therefore face the side aperture 44.Notch portions 113 on which the loop portions 112 are to be hookedindividually are cut near the far-side ends of the two hollow needles92. The opposite ends of the side aperture 44 have curved surfaces 86.

How the sixth embodiment operates will be described.

In the sixth embodiment, the suture threads 111 are passed through thesuture thread sheaths 110 in advance. The insertion section 3 of theendoscope 1 is inserted into the patient's body cavity, with the loopportions 112 mounted on the far-side ends of the threads positioned inthe side aperture 44 of the cap 19.

As in the first and fourth embodiments, the tissue portions 50 a and 50b are held by the grasping portion 17 and drawn into the space 30 of thecap 19. The needle slider 96 of the puncture control portion 94 is movedforward after the tissue portions 50 a and 50 b are drawn into the space30 of the cap 19. The two hollow needles 92 advance simultaneously. Thehollow needles 92 are guided through the guide bores 98, bent guide bore99, and vertical guide bore 100 as they advance. As FIG. 31 shows, thehollow needles 92 that hold the staple 103 penetrate the tissue portions50 a and 50 b and project from the side aperture 44.

The loop portions 112 are opposed to the side aperture 44 as this isdone. The respective far-side ends of the hollow needles 92 thereforepass through the loop portions 112, respectively. The notch portions 113face the loop portions 112. When the suture threads 111 are drawn in onthe side of the control section 2 of the endoscope 1 in this state, theloop portions 112 are anchored to the notch portions 113, as shown inFIG. 32.

The needle slider 96 is then retreated, drawing the hollow needles 92out of the tissue portions 50 a and 50 b. Only the two suture threads111 are left in the tissue portions 50 a and 50 b, as shown in FIG. 33.

The insertion section 3 of the endoscope 1 is then drawn out of the bodycavity. The two suture threads 111 pass through the tissue portions 50 aand 50 b. Finally, the opposite end portions of the two suture threads111 are exposed outside the patient's body, as shown in FIG. 34A. Thetwo suture threads 111 so far remaining in the suture thread sheaths 110are first tied to form a first knot 114 outside the patient's body.

If the suture threads 111 having so far been in the hollow needles 92are then drawn out to the hand side, the first knot 114 is introducedinto the body cavity and touch the flank of the one tissue portion 50 a,as shown in FIG. 34B.

In this state, the suture threads 111 having so far been in the hollowneedles 92 are tied to form a second knot 115 outside the patient'sbody. This second knot 115 is passed through the forceps channel 11 ofthe endoscope 1, and the endoscope 1 is inserted into the patient's bodycavity and pushed into the patient's body cavity by means of theconventional knot pusher. When the second knot 115 reaches a region nearthe tissue portion 50 b, the knot pusher is pressed against the tissueportion 50 b. At the same time, the opposite ends of the suture threads111 are pulled, and the second knot 115 is fixed.

The above-described operation is carried out once or repeated aplurality of times, and the second knot 115 is firmly fixed lest it beuntied. If those parts of the suture threads 111 which are situated onthe hand side of the second knot 115 are finally cut by means of theendoscopic scissors-type forceps or the like, the tissue portions 50 aand 50 b are sutured, as shown in FIG. 34C. Finally, the remaining partsof the suture threads 111 are recovered from the patient's body, and theendoscope 1 and the knot pusher are drawn out of the patient's body,whereupon the suture is completed.

While the suture threads 111 must be substantially twice as long as theinsertion section 3 of the endoscope 1, according to the presentembodiment, the tissue portions 50 a and 50 b can be securely suturedwith the suture threads 111 without regard to the size of the tissueportions 50 a and 50 b, especially their thickness.

As an application of the endoscopic suture apparatus described above,mucous membranes around a region that are subjected to endoscopicmucosal resection are gathered to cover the incised region and sutured,in some cases.

The following is a description of an example of endoscopic mucosalresection. First, the configuration of an injection needle 201 forinjecting a local parenteral solution under a mucous membrane andforming an orifice in the mucous membrane will be described withreference to FIGS. 35 to 37.

As shown in FIGS. 35 and 36, the injection needle 201 comprises anelongate outer sheath 202 formed of a flexible tube and an inner sheath203 also formed of a flexible tube.

The outer sheath 202 is composed of a distal end portion 205, aninsertional portion 206, and a hand-side portion 207. Preferably, theouter sheath 202 should be formed of a highly flexible material such asPTFE. Preferably, moreover, the outside and inside diameters of theinsertional portion 206 should range from φ1.5 mm to φ4.0 mm and fromφ1.0 mm to φ3.5 mm, respectively.

As shown in FIG. 37, the distal end portion 205 is composed of aninitial-insertion portion 208, taper portion 209, dilation portion 210,and stopper 211. The distal end portion 205 may be integral with orseparate from the insertional portion 206. Preferably, the distal endportion 205 should be formed of a highly flexible material. Preferably,the outside and inside diameters of the initial-insertion portion 208should range from φ0.7 mm to φ2.0 mm and from φ0.5 mm to φ1.8 mm,respectively. Preferably, moreover, the length of the initial-insertionportion 208 should range from 0.5 mm t 5 mm. The outside and insidediameters of the dilation portion 210 should range from φ1.5 mm to 4 mmand from 1.3 mm to 3.8 mm, respectively. Further, the outside diameterof the dilation portion 210 is larger than the outside diameter of theinitial-insertion portion 208. Furthermore, the outside diameter of thedilation portion 210 is smaller than the outside diameter of theinsertional portion 206. Preferably, moreover, the length of thedilation portion 210 should range from 1 mm to 10 mm.

A stopper 211 is provided so as to connect the proximal end of thedilation portion 210 and the distal end of the insertional portion 206.The stopper 211 extends substantially at right angles to the axialdirection of the dilation portion 210 and the insertional portion 206.The taper portion 209 smoothly connects the initial-insertion portion208 and the dilation portion 210. Preferably, moreover, the length ofthe taper portion 209 should range from 1 mm to 10 mm.

The taper portion 209 and the distal end portion of the insertionalportion 206 are figured with a first marking 212 and a second marking213, respectively. Further, the first marking 212 and the second marking213 may be of any different colors or the same color. The respectiveshapes of the markings are not limited to the ones shown in FIG. 36. Ifthe boundary between the initial-insertion portion 208 and the taperportion 209 can be recognized with ease, moreover, the first marking 212may be formed on the proximal end portion of the initial-insertionportion 208, for example. Alternatively, the initial-insertion portion208 and the taper portion 209 may be coated in different colors. If theboundary between the dilation portion 210 and the insertional portion206 can be recognized with ease, furthermore, the marking configurationsare not limited to the aforesaid ones. For example, the second markingmay be formed on the proximal end portion of the dilation portion 210,or the dilation portion 210 and the insertional portion 206 may becoated in different colors. If the boundaries between individualcomponents can be recognized with ease, the number of markings is notlimited to two, naturally.

The following is a description of the inner sheath 203. The inner sheath203 is composed of a needle 214, needle stopper 215, liquid feed tube216, and hand-side control portion 217. Preferably, the outside andinside diameters of the liquid feed tube 216 should range from φ0.8 mmto φ3.3 mm and from φ0.6 mm to 3 mm, respectively. The needle 214 isfixed to the liquid feed tube 216 by adhesive bonding on the distal endside of the liquid feed tube 216, and is further fixed to the needlestopper 215 by adhesive bonding on the distal end side of the liquidfeed tube 216. The needle 214 and the needle stopper 215 may be fixed bythermal welding or the like instead of being fixed by adhesive bonding.

The liquid feed tube 216 is fixed to the hand-side control portion 217by adhesive bonding on the hand side. The inner sheath 203 can be slidin the outer sheath 202 by moving the hand-side control portion 217 backand forth. Further, the needle stopper 215 restricts the length ofprojection of the needle 214 from the outer sheath 202 by interferingwith the stopper 211 of the outer sheath 202.

The operation of the injection needle 201 will now be described withreference to FIGS. 38 to 42. First, the endoscope (not shown) isinserted into a target region, and the injection needle 201 is caused toproject from the distal end of the endoscope, as shown in FIG. 38.Thereafter, the needle 214 is caused to project from the distal endportion of the outer sheath 202 of the injection needle 201, and aphysiological saline or other solution is injected under a mucousmembrane 222 of an organ by means of the needle 214. The higher theviscosity of the solution, the longer the bulging time of the mucousmembrane 222 is. Thus, a procedure can be carried out with safety. Ahighly viscous liquid can be fed easily if the inside diameter of theliquid feed tube 216 is large enough. As this is done, theinitial-insertion portion 208 of the outer sheath 202 is also insertedunder the mucous membrane in advance. Since the first marking 212clearly defines the boundary between the initial-insertion portion 208and the taper portion 209, moreover, the initial-insertion portion 208alone can be easily inserted under the mucous membrane.

Then, the needle 214 is pulled into the outer sheath 202 by operatingthe hand-side control portion 217, as shown in FIG. 39. As this is done,the initial-insertion portion 208 alone underlies the mucous membrane.Since the initial-insertion portion 208 is long enough, it can neverslip out from under the mucous membrane at that time.

Then, the outer sheath 202 is pushed in to the depth of the dilationportion 210, as shown in FIG. 40. The taper portion 209 is smooth enoughto allow the outer sheath 202 to be easily pushed into it. As this isdone, the needle 214 is held in the outer sheath 202, and besides, thedistal end portion 205 is soft enough, so that a muscularis 218 cannotbe damaged when the structure is pushed in.

Further, the second marking 213 clearly defines the boundary between thedilation portion 210 and the insertional portion 206, and the stopper211 is caught by the mucous membrane 222, so that the outer sheath 202cannot be inserted too deep. After the outer sheath 202 is inserted tothe depth of the dilation portion 210, the outer sheath 202 is drawn outfrom under the mucous membrane. As this is done, an orifice 219 is boredin the mucous membrane 222, as shown in FIG. 41. Thereafter, the mucousmembrane alone is incised by using a diathermy knife 221 described inJpn. Pat. Appln. KOKAI Publication No. 8-299355, the knife having aninsulated tip 220 on its distal end, as shown in FIG. 42, for example.The orifice 219 that is formed by the injection needle 201 is largeenough to allow the insulated tip 220 to be easily inserted under themucous membrane. Thus, only the one injection needle is needed to injectthe solution under the mucous membrane and form the orifice, so that thetrouble of replacing operative instruments can be saved.

Additional advantages and modifications will readily occur to thoseskilled in the art. Therefore, the invention in its broader aspects isnot limited to the specific details and representative embodiments shownand described herein. Accordingly, various modifications may be madewithout departing from the spirit or scope of the general inventiveconcept as defined by the appended claims and their equivalents.

1-11. (canceled)
 12. An endoscopic suture apparatus comprising: aholding member having a connecting portion provided on a proximal endside thereof for connecting the holding member to a distal end portionof an insertion section of an endoscope, the holding member and thedistal end portion of the insertion section defining a treatment space,and the holding member having an opening portion provided on a distalend side thereof, through which a living tissue is retreated into thetreatment space while the living tissue is urged by the opening portion;a puncture member provided for the holding member to be relativelymovable with respect to the holding member and to puncture the livingtissue retreated into the treatment space; a driving member configuredto move the puncture member, the driving member being connected to thepuncture member on a distal end side and to a puncture control member ona proximal end side; and a suture member configured to puncture theliving tissue according to puncture of the puncture member, the suturemember suturing the living tissue and kept in a living body.
 13. Anendoscopic suture apparatus comprising: a holding member having aconnecting portion provided on a proximal end side thereof forconnecting the holding member to a distal end portion of an insertionsection of an endoscope, the holding member and the distal end portionof the insertion section defining a treatment space, and the holdingmember having an opening portion provided on a distal end side thereof,through which a living tissue is retreated into the treatment space; apuncture member provided for the holding member to be relatively movablewith respect to the holding member and to puncture the living tissueretreated into the treatment space; a driving member configured to movethe puncture member, the driving member being connected to the puncturemember on a distal end side and to a puncture control member on aproximal end side; a pressing member provided for the holding membernear the opening portion and to press the living tissue at least whenthe puncture member punctures the leaving tissue; and a suture memberconfigured to puncture the living tissue according to puncture of thepuncture member, the suture member suturing the living tissue and keptin a living body.
 14. The endoscopic suture apparatus according to claim13, wherein the pressing member includes a base member positioned on theforward side of puncture member in a moving direction thereof to preventthe living tissue to move together with the puncture member when thepuncture member moves forwardly in the moving direction and puncturesthe living tissue.
 15. The endoscopic suture apparatus according toclaim 14, wherein the pressing member further includes an urging memberfor urging the base member in a direction opposite to the movingdirection of the puncture member.
 16. The endoscopic suture apparatusaccording to claim 13, wherein the opening portion is provided on aforward side of the insertion section of the endoscope, and thetreatment section is provided in a distal end portion of the holdingmember between the opening portion and the insertion section.
 17. Amethod for suturing a living tissue comprising: introducing a holdingmember connected to a distal end of an endoscope on a proximal end side,into a living body; retreating a living tissue into holding member froman opening portion formed in a distal end portion of the holding member,in a state where the living tissue is urged so that opposite sides ofliving tissue are approached to each other, the living tissue then beingkept in the holding member; puncturing the living tissue to one side ofthe opposing sides from the other side thereof with a suturing member,so that the living tissue is sutured by the suturing member puncturedthrough the living tissue; and removing the holding member from theliving body.